Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

NCT02484040 | Unknown Phase 3 DMC

• 1 other identifier: TwoArc trial
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.

Conditions

Response to Toxin; Toxicity; Recurrence

Keywords

tumor response; toxicity; recurrence; chemoradiotherpy; rectum

Outcome Measures

Primary Outcomes (1)

• Tumor response from stage II-III to stage 0-I

  Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)

  from clinical staging time to radical surgery date (about 3 months)

Secondary Outcomes (2)

• Toxicity (acute and chronic)

  from radiation start to 3 years after radical surgery

• Recurrence and survival

  3-year recurrence-free survival and 3-year overall survival

Study Arms (2)

Two-week course arm

EXPERIMENTAL

Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine. Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid

Radiation: Two-week course of radiation; Drug: Two-week course of radiation

Conventional arm

NO INTERVENTION

conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid

Interventions

Two-week course of radiation RADIATION

33 Gy in 10 fractions for 2 weeks

Also known as: experimental arm

Two-week course arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed adenocarcinoma;
• distal margin of the tumor located \< 10 cm from the anal verge;
• cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
• no evidence of distant metastasis;
• Karnofsky performance score over 70;
• adequate bone marrow, liver, and renal function (leucocytes \>4000/mm3, hemoglobin \>10 g/dL, platelets \>100,000/mm3; serum bilirubin \<1.5 mg/dL, serum transaminase \<2.5 times the upper normal limit; serum creatinine \<1.5 mg/dL).

You may not qualify if:

• Metastatic disease
• No complete resection of tumor (R2)

Sponsors & Collaborators

• Jong Hoon Lee: lead

Study Sites (1)

Lee Jong Hoon

Suwon, South Korea

RECRUITING

Related Publications (1)

• Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.

  PMID: 24411228 RESULT

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jong Hoon Lee, MD

  St. Vincent's Hospital, The Catholic University of Kora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Hoon Lee, MD

CONTACT

+82-031-249-8440; koppul@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 29, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2021
• Last Updated: June 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)